Global Regulatory Lead, Immunology – Senior Scientist

Merck; Cheyenne (WY); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Bonus eligibility

Benefits package

Job summary

Merck is seeking a Senior Director, Regulatory Affairs Liaison, to develop and lead worldwide regulatory strategies for immunology-focused programs. You will serve as the global regulatory lead, coordinating with development teams and major health authorities to streamline labeling and approvals.

Strong leadership and cross-functional collaboration are essential. You will oversee interactions with agencies like FDA/EMA, prepare for advisory committees, and manage global submissions across

Qualifications

• B.S. or M.S. with a minimum of 10 years of relevant drug development experience, majority in regulatory.
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies.
• Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for developmental compounds or marketed products throughout the entire product life cycle.
• Leads cross-functional efforts to prepare for FDA advisory committees, as applicable.
• Coordinates the preparation, submission and follow-up communications with regulatory agencies and is responsible for regulatory review of global applications and associated documentation.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Immunology

Education

B.S. or M.S. with 10+ years in regulatory/drug development

M.D. or PhD/PharmD with 7+ years in regulatory

Job description

Merck is seeking a Senior Director, Regulatory Affairs Liaison, to develop and lead worldwide regulatory strategies for immunology-focused programs. You will serve as the global regulatory lead, coordinating with development teams and major health authorities to streamline labeling and approvals.

Strong leadership and cross-functional collaboration are essential. You will oversee interactions with agencies like FDA/EMA, prepare for advisory committees, and manage global submissions across